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20,029 catalysts · 4,728 grant · 3,655 8k filing · 2,716 approval · 2,690 device 510k · 2,000 device recall · 1,894 device pma
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20,029 catalysts · 4,728 grant · 3,655 8k filing · 2,716 approval · 2,690 device 510k · 2,000 device recall · 1,894 device pma
Sponsor: HIKMA PHARMS. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: B BRAUN MEDICAL. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Abbreviated
Product code: QEZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: FCG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MUH. Advisory committee: Dental. Type: Traditional
Product code: DWJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: CFR. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: PHL. Advisory committee: Physical Medicine. Type: Traditional
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Special
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Special
Product code: GJS. Advisory committee: Hematology. Type: Special
Product code: NKG. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: SBB. Advisory committee: PA. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OOB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QJA. Advisory committee: EN. Decision: OK30
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing